A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Demonstrate Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 1)
Phase of Trial: Phase III
Latest Information Update: 18 Mar 2018
At a glance
- Drugs A 4250 (Primary)
- Indications Intrahepatic cholestasis
- Focus Registrational; Therapeutic Use
- Sponsors Albireo Pharma
- 14 Nov 2017 According to a company media release, Albireo submitted the study protocol and is currently addressing refinements suggested by the FDA, with no change to the key study design details previously announced. Albireo now expects to initiate this trial by the spring of 2018.
- 21 Aug 2017 According to an Albireo Pharma media release, this trial is expected to begin by the end of 2017.
- 18 May 2017 According to an Albireo Pharma media release, company has finalised key design for this study following consultations with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).